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Background: Monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway have shown good efficacy in migraine prophylaxis. However, a subset of patients does not respond to the first mAb treatment and switches among the available mAbs. The goal of this study is to characterize the switching pattern of migraine patients treated with anti-CGRP(-receptor, -R) mAbs, and to describe the headache burden of those who did not switch, switched once, and switched twice. Methods: This study used real world data from the NeuroTransData Cohort, a registry of migraine patients treated at outpatient neurology clinics across Germany. Patients who had received at least one anti-CGRP(-R) mAb were included. Headache diaries were collected at baseline and during treatment, along with quality of life measures every three months. Results were summarized for the subgroups of patients who did not switch and those with one and two switches. Results: Of the 655 eligible patients, 479 did not switch, 135 switched once, 35 twice, and 6 three or more times. The ≥ 50% response rates for monthly migraine days were 64.7%, 50.7%, and 25.0% for the no switch, one switch, and two switches groups in their last treatment cycles, respectively. Quality of life measures improved for the no switch and one switch groups, but not for the two switches group. Conclusion: Patients who switched among anti-CGRP(-R) mAbs during the course of their treatment still benefited overall but to a lesser extent than those who did not switch. Treatment response in patients who switched twice was markedly lower compared to the no switch and one switch subgroup. [ABSTRACT FROM AUTHOR]

Background: Switching between antibody classes might be a treatment option in migraine patients who have not responded to one class of a CGRP-(receptor) monoclonal antibody (mAb), but there are no efficacy data so far. In this real-world analysis, we assessed the treatment response to a CGRP-mAb in patients that have previously failed the CGRP-receptor-mAb erenumab. Methods: We analyzed retrospective headache diary data of 78 patients with migraine who switched between CGRP-mAbs classes at four German headache centers either due to lack of efficacy or intolerable side effects. Among these, we identified 25 patients who did not respond to erenumab after three treatment cycles (defined as <30% reduction of monthly headache days) and had complete headache documentation at least one month before and during both treatments. We assessed the ≥30% responder rate at month three after switching from erenumab to a CGRP-mAb (galcanezumab or fremanezumab) (primary endpoint). Secondary endpoints included ≥50% responder rate, monthly headache days, and monthly days with acute medication use. In an exploratory subgroup analysis patients were stratified for daily and non-daily headache. Results: The switch from erenumab to a CGRP-mAb led to a ≥30% response in one-third (32%) of the patients after three treatment cycles. A ≥50% response was achieved in 12% of the patients. Monthly headache days were reduced in month three compared to baseline (20.8 ± 7.1 to 17.8 ± 9.1; p = 0.009). Stratified analysis revealed that no patient with daily headache (n = 9) responded to the treatment switch, while a 30% response was achieved by 50% of patients with non-daily headache (n = 16). Conclusion: Our findings demonstrate that a relevant proportion of erenumab non-responders might benefit from a treatment switch to a CGRP-mAb. Switching seems to be a promising treatment option especially in migraine patients with non-daily headache. [ABSTRACT FROM AUTHOR]

Das Wirtschaftsstrafrecht sei beispielsweise dadurch gekennzeichnet, dass die Verfahrensbeteiligten prozessual häufig über das Verfahrensergebnis, den Verfahrensstoff und die Verfahrensregeln einzelfallbezogen verhandelten und somit u. U. von den formal bindenden Normen der Strafprozessordnung in der Weise abwichen, dass die Normen nicht angewendet würden oder die Rechtsfolgen nicht einträten. Professor I Singelnstein i kam unter dem Stichwort der "Gesellschaftlichen Praxis der Kriminalisierung" letztlich zu dem Schluss, dass es im Bereich der Fahrlässigkeit stärker als bei Vorsatztaten an dem aus gesellschaftlicher Perspektive eine Strafe rechtfertigenden Umstand fehle, dass neben die Abweichung von einer Norm die Abweichung der jeweiligen Täter vom durchschnittlichen Lebensstil der Gesamtbevölkerung trete. Professor I Singelnstein i ergänzte, dass auch er davon ausgehe, dass die Fahrlässigkeitsstrafbarkeit in der Praxis vor allem die Funktion hat, die Verursachung schwerer Folgen für die Gesellschaft sichtbar zu sanktionieren. Das bedeute, dass, wenn die Verantwortung in Bereichen, in denen Großschäden drohen, nicht wirklich gerecht dem Individuum zuzurechnen sei, die Scheinwaffe auf die Institutionen und die Möglichkeiten gerichtet werden müsste, die dort etwas ausrichten können. Insbesondere sollten nach dem Konzept der Veranstalterin und der Veranstalter der Hannoveraner Tagung die Fragen erörtert werden, was die Kriminalisierung fahrlässigen Verhaltens antreibe, wohin diese führe, wie die Argumente derer zu beurteilen seien, die die Fahrlässigkeit entkriminalisieren wollten und ob die Ausweitung der Fahrlässigkeitsstrafbarkeit nicht die Freiheit, Risiken einzugehen, gefährde. [Extracted from the article]